Kornimate/medical-research-clean huggingface dataset:
extended-release rancad in the patients with stable angina pectoris

Conditions: Stable Angina Pectoris

Summary: a double-blind, randomized, placebo-controlled, parallel study to evaluate the effects of add-on rancad on exercise tolerance and angina frequency in patients with stable angina pectoris.

primary objective is to to determine the effects of add-on rancad on exercise treadmill test (ett) duration at trough plasma level of rancad level after 12-weeks therapy.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥ 20 years old 2. a minimum 3-month history of stable angina 3. patients with diagnosis of coronary artery disease (cad) 4. patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ett qualifying test 5. patients developed exercise-induced ecg ischemiai during two qualifying exercise treadmill testsii. the difference between twoiii tests should be ≤ 20% of the longer test or ≤ 1 minute i. exercise-induced ecg ischemia is defined as the new development of horizontal or down-sloping st-segment depression of ≥1mm at 60-80ms after the j point; if patients with baseline st depression at rest (\ 20% of the longer test or \>1 minute 6. willing and able to provide a written informed consent exclusion criteria: 1. factors that might compromise ecg or ett interpretation * patients with resting st-segment depression ≥ 1mm in any lead * left bundle-branch block * patients implanted with pacemaker * patients under digitalis therapy 2. patients with family history of (or congenital) long qt syndrome 3. patients with congenital heart disease 4. patients with uncorrected valvular heart disease 5. patients with unstable angina, or mi, or coronary revascularization procedure ≤ 2 months prior enter this study 6. female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential\* who is not using medically recognized method of contraception \*other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal. 7. patients are under any one of the following conditions: * new york heart association (nyha) class iii or class iv congestive heart failure (chf) * qtc \> 450 msec at screening * active myocarditis, pericarditis, hypertrophic cardiomyopathy * uncontrolled hypertension (defined as sbp \> 180 mmhg) voltage criteria for left ventricular hypertrophy in the absence of repolarization abnormalities will not be exclusion criteria 8. use of any investigational product ≤ 4 weeks prior to screening 9. patients with severe hepatic disease (e.g., liver cirrhosis) 10. patients with impaired renal function (defined as serum cr \>1.5 mg/dl) 11. patients with any condition or disease which is considered not suitable for this study by investigator

Keywords: rnta06 rancad
gene - exercise research study

Conditions: Cardiovascular Disease Risk Factors

Summary: the investigators hypothesize that the degree to which older generally healthy but sedentary men and women improve a number of cardiovascular (cv) disease risk factors with 6 months of highly-standardized endurance exercise training will be a function of common genetic variations in candidate genes.


Eligibility criteria:
inclusion criteria: * generally healthy * free from cv disease * ability to undergo exercise training exclusion criteria: * previous history of cv disease

Keywords: plasma lipoprotein lipids body composition glucose tolerance inflammation markers insulin sensitivity coagulation markers
curcumin bioavailability in glioblastoma patients

Conditions: Patient Harboring Glioblastoma That Will Undergo Surgery

Summary: measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma patients.


Eligibility criteria:
inclusion criteria: * patients harboring glioblastoma * patient will undergo surgery exclusion criteria: * bmi \> 30 * liver and kidney function so compromised that medication is prescribed
microcirculatory oxygen uptake in sepsis

Conditions: Sepsis; Severe Sepsis; Septic Shock

Summary: forearm vasoocclusive testing (vot) will be performed with laser-doppler spectrophotometry system in septic patients on icu. microcirculatory oxygen uptake will be checked for prognostic value and for associations with tissue hypoxia markers and high central venus saturations.

sepsis remains a common entity in critical care patients with remarkable mortality. microcirculatory dysfunction plays a pivotal role in the pathophysiology of sepsis and organ dysfunction. the main causal mechanisms are vasoactive substances such as nitric oxide and endothelin, destroyed endothelial surfaces and microvascular occlusion by activated coagulation and leucocytes. furthermore there is some knowledge from vasooclussive testing (vot) based on near-infrared spectroscopy (nirs) and assessing the proportion of perfused vessels determined with orthogonal polarization spectral and sidestream darkfield imaging techniques (sdf) that impaired microcirculation is associated with organ dysfunction and increased mortality. despite these well-recognised evidence previous trails proving therapy guidance with microcirculatory parameters failed in demonstrating optimised outcome . recent guidelines still recommend fluid therapy based on central venous pressure, mean arterial pressure, urine output and or blood lactate concentration. but especially the parameter central venous oxygen saturation (scvo2) seems to be not unproblematic. retrospective data analysis found higher mortality rates if scvo2 is elevated. in the present study patients with sepsis, severe sepsis and septic shock will be evaluated on day 1 and day 4 and a follow up will be performed on day 180. additional to clinical parameters of organ function, infection markers, global parameters of tissue hypoxia will be captured by measurements of adenosine and whose metabolites. macrocirculatory cardiovascular function delivered by transpulmonary thermodilution technique will be assessed and local tissue perfusion and oxygen uptake will be measured with a transcutaneous laser-doppler spectrophotometry system in vot. the aim of this study is to check: 1. is microcirculatory oxygen uptake a prognostic value in sepsis? 2. is it correlated with biomarkers of hypoxia? 3. are high levels of scvo2 caused by microcirculatory impairments or by hyperdynamic macrocirculation?

Eligibility criteria:
inclusion criteria: * criteria according to the ssc for sepsis, severe sepsis and septic shock * admission to the icu within 24 hours exclusion criteria: * pregnancy * cardiopulmonary resuscitation within the last 5 days

Keywords: microcirculation oxygen uptake hypoxia adenosine central venous saturation hypoxanthine laserdoppler
pd1 inhibitors combined with clostridium butyricum for urothelial carcinoma

Conditions: Bladder (Urothelial, Transitional Cell) Cancer

Summary: this study intends to explore whether the combination of clostridium butyricum can improve the current situation of poor anti-pd1 treatment effect in patients with bladder cancer.

this study intends to explore whether the combination of clostridium butyricum can improve the current situation of poor anti-pd1 treatment effect in patients with bladder cancer. this study is divided into two parts. one is the patients with neoadjuvant therapy. after 3 cycles of neoadjuvant therapy, to observe whether the patients with clostridium butyricum live tablets have better neoadjuvant therapy efficacy. the other was in patients with adjuvant therapy to see if adjuvant therapy combined with clostridium butyricum could prolong the patient's prognosis.

Eligibility criteria:
inclusion criteria: for neoadjuvant therapy: * t2-t4an0m0 bladder patients for adjuvant therapy: * postoperative pathological stage t3-t4 and/or lymph node metastasis were positive. exclusion criteria: * the researchers evaluated the patients who could not tolerate radical surgery; * previously received systemic chemotherapy or immunotherapy; * there are active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of a large number of hormones and other immunosuppressants; * have had major surgery or major trauma within 28 days before joining the group; * vaccinated with live vaccine within 28 days before joining the group.
evaluation of the respiratory function in renal transplanted children

Conditions: Respiratory Tract Disease; Kidney Transplantation; Pediatric

Summary: objectives: while a respiratory abnormality was found in 50% of pediatric renal transplant recipients in a study conducted in belgium and the netherlands in 2008, the respiratory status of transplanted children in france remains unknown. the primary objective of this study is to assess the prevalence of respiratory impairment and its characteristics in children with renal transplant. the secondary objective is to study its association with some potential risk factors such as immunosuppressive therapy or humoral immunodeficiency. methodology: this interventional study aims to recruit the 385 children currently being followed by 5 french pediatric renal transplant centers between june 2018 and november 2019. a clinical and functional respiratory assessment will be carried out during the routine annual follow-up of the transplant recipient. children with clinical signs of concern or abnormal spirometry will be referred to a respiratory specialist. pharmacokinetic assays of immunosuppressant therapy and the exploration of humoral function will also be performed. the prevalence and type of respiratory abnormalities will be described. logistic regression will be used to explore the association between potential risk factors and impaired respiratory function. expected results: this study will be the first to evaluate the respiratory status of children with renal transplants in france. the prospective, multi- centered nature of the study, in addition to the large cohort size (which represents two thirds of children with renal transplants in france) will guarantee current, reliable, and representative data for the target population. we will provide new knowledge by precisely characterizing the type of lung injury and looking for potential risk factors. if our study confirms the high prevalence of pulmonary impairment in children with renal transplants, systematic monitoring of respiratory function may be recommended to enable early diagnosis and management. the expected individual and public health benefits would be significant by limiting the appearance of long-term, irreversible sequelae (such as non-cystic-fibrosis bronchiectasis) and improving the quality of life of these patients.


Eligibility criteria:
inclusion criteria: * renal transplanted * patients of 2 to 20 years old * followed in one the five centers mentionned above (nantes, necker, robert debré, lyon, lille) exclusion criteria: * disaggrement from the patient and/or his/her legal representant * impossibility to do the pulmonary function test * cystic fibrosis * patient with another transplant (heart, lung, liver)

Keywords: children transplanted kidney transplantation respiratory function pulmonary function tests respiratory disease immunosuppression
induction-maintenance with atazanavir in hiv naïve patients (the induma study)

Conditions: HIV Infections

Summary: the purpose of this study is to compare the proportion of subjects with hiv-1 rna viral load \< 50 c/ml through week 48 of the maintenance phase among hiv-infected subjects with an initial undetectable viral load following an induction phase with an atv/rtv containing haart regimen, when switched to atv versus remaining on atv/rtv, whilst continuing their previous nrti backbone.


Eligibility criteria:
inclusion criteria: * treatment naive hiv-1 infected subjects ( \< 10 days of treatment with any arv). * subjects who have an hiv-1 rna level ≥ 5000 c/ml at screening. * subjects who have a cd4 count ≥ 50 cells/mm3. * men and women, ages 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate). * both females of child-bearing potential and males must utilize effective barrier contraception. other contraception in addition to barrier methods is permitted; refer to the investigator brochure for details regarding potential interactions with atv and some oral contraceptives exclusion criteria: * wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study. * wocbp using a prohibited contraceptive method. caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see investigator brochure for details * women who are pregnant or breastfeeding * women with a positive pregnancy test on enrollment or prior to study drug administration. * presence of a newly diagnosed hiv-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment * primary hiv infection * medical history and concurrent diseases * active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis physical and laboratory test findings * screening laboratory values measured as follows: * grade iv glucose, * grade iv electrolytes, * grade iv transaminases, * grade iv hematology. * hypersensitivity to any component of the formulation of study drug * prior history of taking any arv for more than 10 days * concomitant administration of tenofovir (tdf). * refer to section 6.4.1 which details all prohibited therapies

Keywords: treatment naive hiv-1 infected treatment naive patients
a smartphone application (act on vaping) for vaping cessation in young adults

Conditions: Nicotine Dependence; Nicotine Addiction; Nicotine Use Disorder; Nicotine Vaping; Vaping

Summary: almost one in ten young adults report current e-cigarette use, putting them at risk of developing nicotine addiction and long-term health effects of exposure to inhaled toxicants. despite the need for effective treatments to help these young users quit, very few treatments targeting any type of tobacco use among young adults have been evaluated, particularly for young adults who vape and have unique treatment needs. to address these needs, this trial will evaluate a digital program for young adult e-cigarette users at all stages of readiness to quit called act on vaping.

outline: participants are randomized to 1 of 2 arms. arm i: participants use the act on vaping smartphone app and text messaging program and receive incentivized text messages assessing their vaping status. arm ii: participants receive incentivized text messages check-ins assessing their vaping status.

Eligibility criteria:
inclusion criteria: * age 18-30. * current weekly user of e-cigarette product(s). * owns an android phone or iphone. * has an email address. * united states (us) resident, with a us mailing address. * willing to complete all study procedures. exclusion criteria: * currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation). * member of the same household as another research participant.
rivaroxaban in endovenous laser ablation with and without miniphlebectomy

Conditions: Varicose Veins; Venous Thrombosis; Thromboembolism; Bleeding

Summary: the purpose of this study is to determine retrospectively if the application of rivaroxaban after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the risk of venous thrombosis.

rivaroxaban is an orally active direct factor xa inhibitor, that is used for thrombosis prophylaxis for example in the setting of orthopaedic surgery. in the observed situation rivaroxaban was applied in a dosage of 10mg daily during 5 days after endovenous laser ablation.

Eligibility criteria:
inclusion criteria: * patients age greater than 18 years, informed consent was given. * endovenous laser ablation (evla) of the greater saphenous vein (gsv), autologous saphenous vein (asv) and/or small saphenous vein (ssv) using 1470 nm wavelength radial laser (elves, biolitec, austria) and postinterventional endothermal heat induced thrombosis (ehit) prophylaxis with rivaroxaban. exclusion criteria: patients are ineligible if they had: * an endovenous ablation technique other than evla, * other veins than gsv, asv or ssv treated with evla (i.e. perforators), * postinterventional ehit prophylaxis other than prophylactic dose of rivaroxaban or * informed consent was not given.
a post marketing surveillance as required by philippine food and drug administration

Conditions: Renal Cell Carcinoma

Summary: this is a post marketing surveillance which determines the safety profile of the product to filipinos. this is a fda requirement for registration.

the philippine food and drug administration requires that a post marketing surveillance study be conducted nationwide and enroll approximately 3,000 study patients. in cases where the 3,000 patients will not be met, the total sample size can be reduced to 10% of the volume of drug use during the first year of it being marketed. final sample size will be determined after one year of marketing authorization. the decision to use torisel must be a joint decision made by the subject and the investigator. the investigator must discuss product information with the subject as per usual practice.

Eligibility criteria:
inclusion criteria: * subjects that will be included in this post marketing surveillance study must be consistent with the approved label indication of torisel in the philippines. * as per approved label indication, patients diagnosed with advanced renal cell carcinoma will be the ones eligible to participate in the study. * the decision to prescribe torisel will necessarily precede and will be independent of the decision to enroll the patient into the study. * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * subjects with conditions that are contraindicated with torisel based on the approved local product document in the philippines will be excluded in this study. this condition includes: patients with bilirubin \>1.5 x uln.

Keywords: metastatic renal cell carcinoma
a study of renal microvessel imaging for chronic kidney disease

Conditions: Healthy; Chronic Kidney Diseases

Summary: the purpose of this research is to study the efficacy of ultrasound microvessel imaging for evaluation of chronic kidney disease. definity is an ultrasound contrast agent currently approved by the fda for use on the heart, liver, and urinary tract. this study will look at its effectiveness on the kidney.


Eligibility criteria:
inclusion criteria: - healthy volunteers or chronic kidney disease (ckd) patients with clinically indicated renal biopsy. exclusion criteria: * subjects lacking capacity to consent. * vulnerable subjects such as prisoners; pregnant women; nursing mother. * subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents. * patients with high-risk cardiac diseases.
evaluation of preoperative biliary drainage before pancreatoduodenectomy

Conditions: Pancreatic Cancer; Periampullary Carcinoma

Summary: the purpose of this study is to evaluate the efficacy of preoperative biliary drainage (pbd) which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by observing the prevalence of drainage and surgery related complications, hospital stay, medical cost and life quality compared to surgery alone. it is anticipated that pbd can reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.

obstructive jaundice is a common symptom in patients with pancreatic head cancer or peri-ampullary cancer. it is regarded that proper surgical resection is the only possible way of radical cure for those patients without evidence of metastasis. since high preoperative bilirubin level is suggested to be a risk factor for pancreatoduodenectomy, preoperative biliary drainage has been applied to clinical practice to improve the outcome of surgery. however, results from previous studies have inconsistent results showing that pbd may have adverse effect on patients by elevating the prevalence of complications. since pbd is widely performed worldwide, its value needs to be clarified. thus the present study is designed to systematically evaluate the value of pbd via recruiting participants who may most likely benefit from pbd. it is anticipated that results from this study can present an instructive conclusion on whether pbd should be performed prior to pancreatoduodenectomy as well as reveal the preferable type of pbd.

Eligibility criteria:
inclusion criteria: * 18 to 70 years old * ct (computed tomography), cta (computed tomographic angiography), mri (magnetic resonance imaging) or ultrasonic test suggested pancreatic head carcinoma or periampullary carcinoma with obstructive jaundice * first routine test of serum bilirubin above 250μmol per liter exclusion criteria: * distant metastasis in liver, lung or other sites * invasion of local blood vessels (e.g. aorta, portal vein, postcava) * poor physical condition, unable to tolerate anesthesia and surgery (e.g. severe cardio-pulmonary diseases, blood coagulation disorders) * with cholangitis, active hepatitis or other diseases which should be excluded from study according to the investigators

Keywords: obstructive jaundice preoperative biliary drainage pancreatoduodenectomy
safety and efficacy study of bimatoprost, latanoprost, and travoprost in patients with elevated intraocular pressure (iop) and open-angle glaucoma (oag)

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: to investigate the effectiveness of the newer iop-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.


Eligibility criteria:
inclusion criteria: * a diagnosis of primary open-angle glaucoma or ocular hypertension newly diagnosed or presenting with insufficiently controlled iop on current medication (in the opinion of the treating physician) * patient is having both eyes treated exclusion criteria: * contraindications per product labelling will apply. * patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.